U.S. justices bar patents on genes in humans

Friday

Jun 14, 2013 at 12:01 AMJun 14, 2013 at 11:22 AM

WASHINGTON - A unanimous U.S. Supreme Court yesterday prohibited patents on naturally occurring human genes but allowed legal protections on synthetically produced genetic material in a compromise ruling hailed as a partial victory for patients and the biotechnology industry.

WASHINGTON — A unanimous U.S. Supreme Court yesterday prohibited patents on naturally occurring human genes but allowed legal protections on synthetically produced genetic material in a compromise ruling hailed as a partial victory for patients and the biotechnology industry.

The ruling by the nine justices, the first of its kind for the top U.S. court, buttressed important patent protections relied upon by biotechnology companies while making it clear that genes extracted from the human body cannot be patented.

Researchers and advocates for patients said it could make it easier for people to get cheaper genetic tests for disease risk.

The court’s ruling came in a challenge launched by medical researchers and others to seven patents owned by or licensed to Salt Lake City-based biotechnology company Myriad Genetics Inc. on two genes linked to breast and ovarian cancer.

Myriad’s work on cancer screening gained worldwide attention this year when actress Angelina Jolie announced she had a double mastectomy after undergoing a test and finding she had an extremely high risk of developing breast cancer.

“This is a ruling in favor of patients,” said Rebecca Nagy, a genetic counselor with Ohio State University’s Wexner Medical Center and president of the National Society of Genetic Counselors.

As she spoke yesterday about the ruling, she received an email announcing that another laboratory would offer the BRCA 1 and 2 tests that were previously available only from Myriad at a cost of about $4,000.

Nagy said the hope is that as more labs offer the tests, the cost will go down. Furthermore, the BRCA 1 and 2 tests can now be added to panels of tests for other, rarer mutations that predispose women to breast cancer.

Women who have the Myriad test and learn they do not carry those mutations sometimes then opt for another test that looks for other potential mutations and costs about $2,600 more, Nagy said.

The decision has implications beyond breast cancer and in theory could limit financial obstacles to a variety of genetic tests, she said.

One potential downside of yesterday’s decision is that it could slow research and development of tests that could save or prolong lives because it removes some financial incentive for researchers and those who support their work.

The ruling does allow for patents when DNA is copied in the lab and not in its original form.

“There is some wiggle room,” Nagy said, adding that it’s unclear how everything will play out after the ruling.

The biotech industry noted that the justices left intact patent protections on forms of DNA produced by scientists in laboratories and the processes used to carry out tests such as cancer screenings. The industry had said an expansive ruling against Myriad could have threatened billions of dollars of investment.

The contentious, uniquely 21th-century question before the court was whether any human genes can ever be patented — meaning the holders have exclusive rights to their intellectual property for a defined period. The issue has gained increasing importance as scientists make progress in identifying specific genes, or mutations, linked to a variety of diseases.

The court, in an opinion written by Justice Clarence Thomas, ruled that forms of DNA that have been manipulated in the lab in a way that alters their natural state can be patented.

The compromise outcome had been recommended to the justices by the Obama administration.

Myriad’s shares initially rose nearly 13 percent to as high as $33.87 after the company declared victory yesterday, but shares eventually closed down $1.91, or 5.6 percent, at $32.01 on Nasdaq after potential rivals announced intentions to market BRCA gene tests.

Myriad said the decision left intact 24 patents that relate to the BRACAnalysis test. Peter Meldrum, Myriad’s president and CEO, said the ruling ensures “strong intellectual-property protection for our BRACAnalysis test moving forward.”

The decision “sets a fair and level playing field for open and responsible use of genetic information,” said Dr. Robert Darnell, president and scientific director of the New York Genome Center, an alliance of medical centers and research universities. “At the same time, it does not preclude the opportunity for innovation in the genetic world.”

A group of medical researchers, associations and patients — represented by the American Civil Liberties Union — filed suit in 2009, saying human genes including synthetically produced material should not be patented.